Hermes Medical Imaging Suite V5.2
FDA 510(k) K121278 · Hermes Medical Solutions AB
510(k) numberK121278
Submission
- Device name
- Hermes Medical Imaging Suite V5.2
- Applicant
- Hermes Medical Solutions AB
Stockholm, SE - Received
- April 30, 2012
- Decision date
- December 18, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KPS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261305 | Micsi-PetKPS · Traditional | Microstructure Imaging, Inc. | 09/11/2026SE |
| K261427 | uMI Panvivo (uMI Panvivo M)KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 07/28/2026SE |
| K261315 | Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7…KPS · Special | Siemens Medical Solutions USA, Inc. | 05/21/2026SE |
| K260524 | uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 04/03/2026SE |
| K253564 | uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX)…KPS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/13/2026SE |
| K254001 | VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400…KPS · Special | Spectrum Dynamics Medical, Ltd. | 01/13/2026SE |
| K253844 | AnyScan 3.0 NM Scanner FamilyKPS · Traditional | Mediso Medical Imaging Systems, Ltd. | 12/30/2025SE |
| K251370 | Cartesion Prime (PCD-1000A/3) V10.21KPS · Traditional | Canon Medical Systems Corporation | 12/01/2025SE |
| K251401 | PennPET Explorer Positron Emission TomographKPS · Traditional | Trustees of the University of Pennsylvania | 11/25/2025SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | Hermes Medical Solutions AB | 09/09/2025SE |
More from Hermes Medical Solutions AB
| 510(k) | Device | Decision |
|---|---|---|
| K253835 | AffinityQIH · Traditional | 07/31/2026SE |
| K252477 | Hybrid Viewer (00859873006240)KPS · Special | 09/09/2025SE |
| K243919 | Voxel Dosimetry (00859873006226)QIH · Traditional | 07/30/2025SE |
| K241364 | Hybrid Viewer (00859873006189)KPS · Traditional | 11/08/2024SE |
| K202882 | AffinityKPS · Traditional | 12/23/2020SE |
| K193152 | AffinityKPS · Traditional | 02/14/2020SE |
| K191216 | Voxel Dosimetry v1.0LLZ · Traditional | 10/17/2019SE |
| K181468 | Hybrid3DKPS · Traditional | 10/25/2018SE |
| K171719 | Hybrid3DKPS · Traditional | 11/21/2017SE |
| K171681 | Hermes Medical Imaging Suite v5.7KPS · Traditional | 11/21/2017SE |
Questions and answers
When was Hermes Medical Imaging Suite V5.2 cleared by the FDA?
Hermes Medical Imaging Suite V5.2 (K121278) received a 510(k) decision of Substantially Equivalent on December 18, 2012, 232 days after the submission was received.
What is the product code of K121278?
The FDA product code is KPS – System, Tomography, Computed, Emission, a Class II (moderate risk) device regulated under 21 CFR 892.1200.